FDA Authorizes Use of Drug Applied to President Trump

The United States Health authorities authorized on Saturday the emergency use of a second antibody drug that helps the immune system to fight COVID-19 and that while being experimental was supplied to President Donald Trump when he fell ill last month.

The Food and Drug Administration (FDA) approved the use of the drug by Regeneron Pharmaceuticals Inc., in an attempt to prevent hospitalization and worsening of illness in patients with mild to moderate symptoms.

The medicine is given intravenously as a one-time treatment. The FDA has allowed its use in adults and children 12 years of age and older who weigh at least 40 kilograms (88 pounds) and face an elevated risk of severe COVID-19 due to their age or certain health problems.

The emergency authorization allows the use of the drug to begin while studies continue to establish its safety and efficacy. Initial results suggest that the drug may reduce hospitalizations or emergency room visits for COVID-19 patients at risk of further disease, according to the FDA.

Regeneron noted that the starting doses will be available to about 300,000 patients through a federal government allocation program. Patients will not be charged for the drug, but they may have to pay for the cost of the IV.

Initial supply is likely to be outstripped by demand as reported cases have passed 10 million in the United States, where health experts have said the country will face a dark winter due to the uncontrollable spread of the virus.

Antibodies are proteins that the body makes to attack viruses and help it eliminate them, but it can take weeks for them to be most effective after infection. The drugs are concentrated versions of antibodies that are shown to have this ability in laboratory and animal tests, and theoretically help the body to begin fighting the virus immediately.

Regeneron’s drug combines two antibodies to increase the chances of its effectiveness. Earlier this month, the FDA gave its emergency clearance to an Eli Lilly single-antibody drug that is still under study.

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